Shares of Genta rose 10 cents, or 12.5 percent, to 90 cents in pre-market activity on the INET electronic exchange, after closing at 80 cents on the Nasdaq Monday.
The Australia Therapeutic Goods Administration granted the designation for the drug to treat Stage IV malignant melanoma. The designation is given to drugs meeting underserved diseases, and grants reduced filing fees for market approval, along with seven years of marketing exclusivity if approved.
The Food and Drug Administration is scheduled to make a decision on the drug on Oct. 29. Earlier in the month, the company designed a study with the FDA to further test the drug in treating leukemia, but wants to meet with the agency on its current marketing application before proceeding.
Genta had previously tried to get Genasense approved for advanced skin cancer, but an FDA advisory panel recommended against it in 2004, and the company withdrew the marketing application.

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